Lupin gets USFDA nod for generic drug

Drugmaker Lupin on Friday said it has received approval from the US health regulator to market Droxidopa capsules, used to treat dizziness.

The company has received approval from the US Food and Drug Administration (USFDA) for Droxidopa capsules in strengths of 100 mg, 200 mg, and 300 mg, Lupin said in a statement.

The company's product is a generic version of Lundbeck NA's Northern capsules, it added.

The product will be manufactured at the company's Nagpur-based facility, the Mumbai-based drugmaker noted.

Droxidopa Capsules are indicated for the treatment of orthostatic dizziness, lightheadedness in patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

As per IQVIA MAT December 2020 sales data, Droxidopa capsules had estimated annual sales of USD 352 million in the US.

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